Formulation, Quality Control and Stability Study of Pediatric Oral Dextrose Gel

Area of Science:

• Neonatal care
• Pharmaceutical compounding
• Endocrinology

Background:

• Limited data exists on the stability and quality control of compounded 40% dextrose gel for neonatal hypoglycemia.
• The mechanism of efficacy, specifically buccal absorption, of oral dextrose gel is not well understood.

Purpose of the Study:

• To investigate the stability, microbiological safety, rheological properties, and dextrose diffusion of a compounded 40% oral dextrose gel.
• To ensure the gel can be widely compounded and stored for clinical use in managing neonatal hypoglycemia.

Main Methods:

• Compounded 40% dextrose gel analyzed for dextrose content, degradation products, and microbiological safety.
• Stability assessed at ambient and refrigerated temperatures.
• Rheological properties and in vitro dextrose permeation through an artificial membrane were evaluated.

Main Results:

• The gel demonstrated stability for 7 days at ambient temperature and 90 days refrigerated.
• Dextrose content remained within acceptable limits (90-110%), and microbiological tests confirmed safety.
• In vitro studies showed minimal dextrose diffusion, suggesting stability and suitability for oral administration.

Conclusions:

• The study validates a stable 40% oral dextrose gel formulation for neonatal hypoglycemia management.
• The gel meets quality control criteria and is safe for clinical administration.
• This formulation presents a cost-effective and safe alternative in neonatal care.